Downstream Processing Scientist

Global Life Science Hub is partnered with an incredible biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is transitioning from R&D to a full-scale commercial organization looking to build a new state-of-the-art facility in New Jersey as they ramp up production efforts from 50L to 2000L in Q4.

To support further expansion, we seek a Downstream Processing Scientist responsible for purifying clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF, knowledge of initiating batch records, and experience packing chromatography columns.

Responsibilities:

Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.

Provides technical direction in the execution and development of the purification process.

Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.

Ensure that engineering and clinical batches are executed in a timely manner.

Establishes operating equipment specifications and improves manufacturing techniques.

Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.

Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.

Coordinate the conduction of investigations and corrections for issues found during the batch execution process.

Performs other functions as required or assigned

Complies with all company policies and standards

Experience/Qualifications:

A BSc or MSc in a life science sector

A minimum of 3 years' experience in downstream processing

Previous experience within in an Aseptic Manufacturing environment

Experience running Chromatography systems and packing columns

Ability to run TFF operations

Experience working with AKTA process skids and knowledge of unicorn software is highly desirable

Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.

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Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.

If you're interested, please apply below. If this position doesn't suit you, visit our website for more vacancies -